Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history revealed no other similar incidents.Based on the information provided, the balloon rupture appears to be due to case circumstances.It is likely that the resistance during advancement and rupture occurred due to interaction with lesion calcification.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was performed to treat a 75% stenosed, mildly tortuous, and mildly calcified lesion in the axillary artery.An 8x40mm armada 35 balloon catheter was advanced; however, slight resistance with the anatomy was felt.The balloon ruptured at 15 bars during the second inflation.The procedure was successfully completed with a new unspecified device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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